A dermatological study to evaluate hair thickening spray (Containing Bhringraj and Shikakai) on healthy volunteers

Not Applicable

Active, not recruiting

• Conditions: The objective of this study is to evaluate the efficacy of hair thickening spray (bhringraj and shikakai) on healthy human subjects.

• Registration Number: CTRI/2022/05/042565
• Lead Sponsor: Mountain Valley Springs India Pvt Ltd

Brief Summary

It is a single centre, prospective, open label, non-comparative study to evaluate the efficacy of Hair Thickening Spray (Bhringraj and shikakai) for hair growth, volume and hair thickness in healthy volunteers. This study will be conducted in compliance with applicable national regulations for Post Marketing Surveillance of cosmetic product with the aim of identifying or quantifying safety hazards relating to an authorized cosmetic product and is aligned with various guidelines and recommendations for guideline on PMS practices for cosmetic products.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-18
• Last Update Posted: 2023-09-02

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Healthy subjects (no infectious and evaluative pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory check-up) Indian Male/Female subjects.
• Hair & scalp is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar etc) Between 18 to 65 years of age, with normal Hair condition.
• Written informed consent signed by the subject in line with applicable regulation of country.

Exclusion Criteria

• Having refused to give her consent by not signing the consent form.
• Taking part in another study liable to interfere with this study.
• Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis).
• Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
• Having cutaneous hypersensitivity.
• Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only hair and scalp cleaned with water is accepted).

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation will include assessment of local adverse events of redness, itching, rashes and burning sensations and any other local side effect and will be categorized non serious (based on severity grades, patterns, and causality) and serious adverse events. There will be two types of assessment, subject self-assessment, and dermatological evaluation by study investigator	Subjects will assessed at 30 minutes, 15 days and 30 days after test product application

Trial Locations

Locations (1)

Qaaf Healthcare International; 🇮🇳 South, DELHI, India

Qaaf Healthcare International

🇮🇳South, DELHI, India

Dr Esha Roy

Principal investigator

9254425442

esharoy86@gmail.com